Cleared Traditional

FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

K042824 · CooperVision, Inc. · Ophthalmic
Nov 2004
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K042824 is an FDA 510(k) clearance for the FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on November 16, 2004, 35 days after receiving the submission on October 12, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K042824 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2004
Decision Date November 16, 2004
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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